Not an RPM
Famous Meetings
Know your Guidance
First Job
FDA Campus
100
Tropical beach shack/bar manager
Who is Jennifer
100
Joe Flacco(former Ravens QB)
Sheel
100
If a meeting request is denied, the FDA will notify the requester in writing according to the timelines described in Table 1. The FDA’s letter will include an explanation of the reason for the denial. Denials will be based on a substantive reason, not merely on the absence of a minor element of the meeting request or meeting package items.
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
100
Blockbuster
Joe
100
Building 32, 2, 75, 22
Cafeteria/Cafes
200
Reality TV Star
Who is Deb
200
Trick Daddy
Jennifer
200
This guidance provides recommendations on applications who intend to make postapproval changes in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act (the Act)
Changes to an Approved NDA or ANDA
200
McDonald’s
Chris
200
Building 2
Do-Ho Suh is a Korean sculptor and installation artist. He was born in Seoul, Korea in 1962.
Best know for his intricate sculptures that defy conventional notions of scale and site-specificity, Suh's work draws attention to the way viewers occupy and inhabit public space.
300
Blood spatter expert (or some type of forensic investigator)
Who is Chris
300
Henry Rollins
Gregory
300
This guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, which established the limited population pathway for antibacterial and antifungal drugs
Limited Population Pathway for Antibacterial and Antifungal Drugs
300
Security Guard at an Art Museum
Faith
300
Jenny Holzer's artwork, black granite benches with inscriptions, are installed outside in the Central Commons area. The inscriptions on the benches with the table at the entrance of this building are the 1960 employee survey questions.
Building 22
400
Museum tour guide
Who is Dheera
400
Patrick Ewing and Sarah Silverman
Joe
400
This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs)2 and drug products should take to detect and prevent unacceptable levels of nitrosamine3 impurities in drug products.
Control of Nitrosamine Impurities in Human Drugs
400
Dishwasher x2
Gregory (13) and Sheel (14)
400
The FDA IT Walk-Up Kiosk is open and ready to assist you. We are a full-service, on-site, handicap accessible, Helpdesk kiosk that provides technical Tier 2 support for customers who prefer or need an alternate option for expedited assistance. When in need of IT assistance, FDA employees and contractors can stop by for help on a first-come, first-served basis.
White Oak Building 52, 2nd floor, located in an open area near the stairwell
500
Soccer player
Who is Claire
500
Serena Williams
Deb
500
This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
500
Sbarro Pizza (in White Flint Mall)
Claire
500
7 locations with 16 male & 16 female facilities
Showers
Buildings 22, 32, 51, 62, 64, 66, & 75